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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Folic, Radioimmunoassay
510(k) Number K103716
Device Name ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact KATHIE J GOODWIN
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact KATHIE J GOODWIN
Regulation Number862.1295
Classification Product Code
CGN  
Subsequent Product Codes
JIT   JJX  
Date Received12/21/2010
Decision Date 05/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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